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The combination of chidamide with the CHOEP regimen in previously untreated patients with peripheral T-cell lymphoma: a prospective, multicenter, single arm, phase 1b/2 study

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收录情况： ◇ SCIE ◇ 统计源期刊 ◇ CSCD-C ◇ 卓越：重点期刊

作者：
Zhang Wei[1] * ; Su Liping[2] ; Liu Lihong[3] ; Gao Yuhuan[3] ; Wang Quanshun[4] ; Su Hang[5] ; Song Yuhuan[6] ; Zhang Huilai[7] ; Shen Jing[8] ; Jing Hongmei[9] ; Wang Shuye[10] ; Cen Xinan[11] ; Liu Hui[12] ; Liu Aichun[13] ; Li Zengjun[14] ; Luo Jianmin[15] ; He Jianxia[16] ; Wang Jingwen[17] ; O'Connor O A[18] ; Zhou Daobin[1] ;
机构： [1]Department of Hematology, Peking Union Medical College Hospital, Beijing 100730, China [2]Department of Hematology,Shanxi Provincial Cancer Hospital, Taiyuan 030013, China [3]Department of Hematology, Fourth Hospital of Hebei MedicalUniversity, Shijiazhuang 050011, China [4]Department of Hematology, Chinese PLA General Hospital, Beijing 100039, China [5]Department of Lymphoma, the 307 Hospital of PLA, Beijing 100071, China [6]Department of Lymphoma, Peking UniversityCancer Hospital and Institute, Beijing 100142, China [7]Department of Lymphoma, Tianjin Medical University Cancer Instituteand Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’sClinical Research Center for Cancer, Tianjin 300060, China [8]Department of Hematology, Beijing Friendship Hospital, Beijing100050, China [9]Department of Hematology, Peking University Third Hospital, Beijing 100191, China [10]Department ofHematology, the First Affiliated Hospital of Harbin Medical University, Harbin 150081, China [11]Department of Hematology,Peking University First Hospital, Beijing 100034, China [12]Department of Hematology, Beijing Hospital, Beijing 100730, China [13]Department of Lymphoma, Harbin Medical University Cancer Hospital, Harbin 150081, China [14]Lymphoma Diagnosis andTreatment Center, Institute of Hematology and Blood Diseases Hospital, Tianjin 300052, China [15]Department of Hematology,Second Hospital of Hebei Medical University, Shijiazhuang 050000, China [16]Department of Hematology, Shanxi ProvincialPeople’s Hospital, Taiyuan 030012, China [17]Department of Hematology, Beijing Tongren Hospital, Beijing 100730, China [18]Columbia University Medical Center, New York 10032-3784, NY, USA
出处：
DOI： 10.20892/j.issn.2095-3941.2020.0413
ISSN：

关键词： Peripheral T-cell lymphoma chidamide histone deacetylase inhibitor epigenetic

摘要：
To assess the efficacy and safety of the novel histone deacetylase inhibitor, chidamide, in combination with cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone (Chi-CHOEP) for untreated peripheral T-cell lymphoma (PTCL). A prospective, multicenter, single arm, phase 1b/2 study was conducted. A total of 128 patients with untreated PTCL (18-70 years of age) were enrolled between March 2016 and November 2019, and treated with up to 6 cycles with the Chi-CHOEP regimen. In the phase 1b study, 3 dose levels of chidamide were evaluated and the primary endpoint was determination of the maximum-tolerated dose and recommended phase 2 dose (RP2D). The primary endpoint of the phase 2 study was 2-year progression-free survival (PFS). Fifteen patients were enrolled in the phase 1b study and the RP2D for chidamide was determined to be 20 mg, twice a week. A total of 113 patients were treated at the RP2D in the phase 2 study, and the overall response rate was 60.2%, with a complete response rate of 40.7%. At a median follow-up of 36 months, the median PFS was 10.7 months, with 1-, 2-, and 3-year PFS rates of 49.9%, 38.0%, and 32.8%, respectively. The Chi-CHOEP regimen was well-tolerated, with grade 3/4 neutropenia occurring in approximately two-thirds of the patients. No unexpected adverse events (AEs) were reported and the observed AEs were manageable. This large cohort phase 1b/2 study showed that Chi-CHOEP was well-tolerated with modest efficacy in previously untreated PTCL patients. Copyright © 2021 Cancer Biology & Medicine.

基金：
National Natural Science Foundation of China (Grant No. 81970188) and the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (Grant No. 2016-12M-1-001)
语种：
外文
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出版当年[2020]版：
大类 | 1 区 医学
小类 | 1 区 医学：研究与实验 2 区 肿瘤学
最新[2023]版：
大类 | 2 区 医学
小类 | 3 区 医学：研究与实验 3 区 肿瘤学
JCR分区：
出版当年[2019]版：
Q1 ONCOLOGY Q1 MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版：
Q1 MEDICINE, RESEARCH & EXPERIMENTAL Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2019版] 出版当年五年平均 出版前一年[2018版] 出版后一年[2020版]

第一作者：
第一作者机构： [1]Department of Hematology, Peking Union Medical College Hospital, Beijing 100730, China
通讯作者：
推荐引用方式(GB/T 7714)：
Zhang Wei,Su Liping,Liu Lihong,et al.The combination of chidamide with the CHOEP regimen in previously untreated patients with peripheral T-cell lymphoma: a prospective, multicenter, single arm, phase 1b/2 study[J].CANCER BIOLOGY & MEDICINE.2021,18(3):841-848.doi:10.20892/j.issn.2095-3941.2020.0413.
APA：
Zhang Wei,Su Liping,Liu Lihong,Gao Yuhuan,Wang Quanshun...&Zhou Daobin.(2021).The combination of chidamide with the CHOEP regimen in previously untreated patients with peripheral T-cell lymphoma: a prospective, multicenter, single arm, phase 1b/2 study.CANCER BIOLOGY & MEDICINE,18,(3)
MLA：
Zhang Wei,et al."The combination of chidamide with the CHOEP regimen in previously untreated patients with peripheral T-cell lymphoma: a prospective, multicenter, single arm, phase 1b/2 study".CANCER BIOLOGY & MEDICINE 18..3(2021):841-848

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